Engineer Quality
Resume:
Kushal Sandesara
*********@***.***
*** ******** ****** ****: (201)-668-
1218
Walnut, CA 91789
Working in organization, which provides me an opportunity to put my knowledge and skills at work as Validation engineer
and make substantial contribution to growth of organization and myself in current fast paced environment .
SKILLS
Experience with Adverse event Reporting System (AERS), Supply corrective action Report (SCAR) and instruments such as
HPLC, GC, GC-MS, Kaye validator, FTIR, PH meter and UV-VIS. Perform swab sampling for cleaning validation using TOC
(Total Organic Carbon).
Experience in validation practices with a good understanding of GMP, GLP, GCP, GAMP, 21 CFR parts 11 and ISO and ICH
guideline.
Experience in development of validation Protocols like Installation Qualification (IQ), Operational Qualification (OQ) and
Performance Qualification (PQ) for the related application strong Inter-personal communication and organizational skills.
Experience with SOP preparation, FMEA, CAPA, DoE, Cause and Effect Diagram, Quality By Design, Quality tools like Six
Sigma and lean manufacturing.
Expertise in reviewing and preparing validation documents like requirement documents, Validation Master Plans and prepare
and execute protocol.
Proficient in Microsoft Excel, Microsoft Power Point, Microsoft word, Microsoft Outlook, Microsoft Project and Microsoft
Visio.
Work Experience:
Pharmaceutical Services Corporation, Pomona, CA (October 2013-Present)
Validation Engineer
• Validation Master plan generation and validation strategies for process and cleaning validation
• Generation of Cleaning validation, process validation protocols and reports and execution
• Perform review and execution of cleaning validation protocols and cleaning cycle development protocols.
• Generation of protocol reports and Standard Operating Procedures for automated and manual cleaning process.
• Programming and Troubleshooting of CIP skids and CIP systems for HV fillers, Tanks and Product transfer lines
• Review executed documents as per Good Documentation Practices
• IQ, OQ and PQ protocol preparation and execution for autoclave, utilities (steam, DI water system, Pure steam system), Dryer,
refrigerators, lyophilizers, labeling and packaging instruments
• Preparation of URS, FRS, SAT, FAT and commissioning documents
• Computer system validation for document management system
Pharmaeceutical Innovations Inc, Newark, NJ (June 2012-September 2013)
Regulatory Specialist
• Performed Sterilization validation and calibration using kaye validator
• Performed and collected swab samples and rinse samples
• Performed review, approval and execution of cleaning validation protocols and cleaning cycle development
• Audited vendors to ensure compliance with GMP practices.
• Preparation and submission of technical files for CE mark.
• Handling FDA and ISO 13485 and ISO 9001 audits and facilitate successful completion of audits
• Maintained Adverse drug reaction event system
• Supplier evaluation and audits
• Identifying root cause of the problem and prepare Supply Corrective Action Report (SCAR).
• Implementation and improvement of Quality Management system
• Reviewing and identify the cause of non-conformity product and prepare CAPA log.
• Review and preparation of Quality Manual and review according to FDA and ISO 13485guideline.
Stevens Pharmaceutical Research Center (Jan 2011-Dec2011)
Validation Specialist (Cleaning Validation, Process Validation and Equipment Validation)
Developed Validation Plans for small to medium size validation projects, qualification and validation of equipment, facilities,
utilities, as well as cleaning, sterilization, and manufacturing processes.
Worked under direct guidance to apply GMP validation principles in accomplishing project goals.
Performing Part 11 assessment, especially contributing to the components involved in maintenance of Electronic Records (ER),
Electronic Signatures (ES) and audit trail in accordance with 21 CFR part 11 regulations.
Created and executed Validation Master Plan depending on the FMEA.
Prepared and executed OQ & PQ, Process Validation as well as Cleaning Validation Protocol as per User Requirements.
Prepared and validated a Spreadsheet for measuring the Content Uniformity of the main ingredient.
Prepared a Final Validation Summary Reports.
had undergone Pre-Approval Inspection for the entire manufacturing process.
Working on Cleaning Validation, to analyze the product integrity and its behavior in regards to the respective cleaning agents.
Preparation and execution of Cleaning Validation Test Protocols using Swab Technique and analyzing the critical areas for
cleaning.
Lincoln Pharmaceutical, Khatraj, India (June 2007-Dec 2009)
Quality Assurance associate.
Validation of analytical methods including protocol and report preparation.
Review and approval of cleaning and process development protocols
Execution of packaging validation protocols
In depth review and approval of validation master plan, cleaning sampling plan, cleaning cycle development and master batch
records
PROJECT AND RESEARCH PROPOSAL
Redesign of current facility according to GMP requirements (Including process flow diagram, HVAC, Room classification, plant
layout, Gowning requirements, Validation and documentation, warehouse).
Preparation and execution IQ/OQ/PQ protocol.
Comparison between EU and US FDA regulations on Advanced therapies.
Validation package for programmable coating equipment, which includes Installation Qualification (IQ), Operational
Qualification (OQ), Validation Master Plan (VMP), User requirement specification (URS), Functional Specification.
Education:
Master of Science in Pharmaceutical Manufacturing
Stevens Institute Of Technology, Hoboken, NJ (December 2011)
Certificates:
Validation and Regulatory affairs
Pharmaceutical Manufacturing Practices
Bachelor in Pharmacy, Pharmaceutical Science
K.B. Institute of Pharmaceutical Education and Research, Gujarat, India (May 2009)
Certification:
RAC (US) Regulatory affairs Professional Society (RAPS)
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